Diabetes Mellitus, Type 1 MedDRA version: 20.0 Level: PT Classification code 10012601 Term: Diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: ultra-rapid formulation of insulin
Product Code: LY900014
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN LISPRO
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Men or women diagnosed (clinically) with T1D for at least 1 year prior to screening, and continuously using insulin for at least 1 year •Are at least 18 years of age •Have been using CSII therapy for a minimum of 6 months prior to screening. Interruption of CSII is allowed during the 6 months prior to screening for up to a total of 14 days, such as during a hospitalization, a pump malfunction, or a “pump holiday” •Must be using a MiniMed 530G or 630G (US), 640G (EU), insulin pump for at least the last 90 days and willing to stay on the same pump throughout the study •Are willing to maintain their current bolus delivery speed (standard or quick) for the duration of the study •Have HbA1c values of =6.5 and =9.0%, as determined by the central laboratory at screening (Visit 1) •Have a body mass index (BMI) of =35.0 kg/m2 at screening (Visit 1) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 380 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: -Have any other condition (including known drug or alcohol abuse or psychiatric disorder including eating disorder) that precludes the patient from following and completing the protocol -Have hypoglycemia unawareness as judged by the investigator -Have had more than 1 episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within 6 months prior to screening -Have had more than 1 emergency room visit or hospitalization due to poor glucose control (hyperglycemia or DKA) within 6 months prior to screening -Have cardiovascular disease, within the last 6 months prior to screening, defined as stroke, decompensated heart failure New York Heart Association class III or IV (CCNYHA 1994), myocardial infarction, unstable angina pectoris, percutaneous transluminal coronary angioplasty or coronary arterial bypass graft Renal: a. History of renal transplantation b. Currently receiving renal dialysis c. Serum creatinine >2.0 mg/dL (177 µmol/L) at screening, or d. An estimated glomerular filtration rate of <30 mL/min/1.73 m2. -Hepatic: have obvious clinical signs or symptoms of liver disease (for example, acute or chronic hepatitis, or cirrhosis), or elevated liver enzyme measurements as indicated below at screening a. Total bilirubin level (TBL) =2X the upper limit of normal (ULN) (with the exception of Gilberts Disease) as defined by the central laboratory, Or b. Alanine aminotransferase (ALT) =3X ULN as defined by the central laboratory, Or c. Aspartate aminotransferase (AST) =3X ULN as defined by the central laboratory -Hematologic: have had a blood transfusion or severe blood loss within 90 days prior to screening or have known hemoglobinopathy, anemia that is clinically significant based on investigator judgement, or any other traits of known to interfere with measurement of HbA1c -Have presence of clinically significant gastrointestinal disease (for example, clinically active gastroparesis associated with wide glucose fluctuations; includes those with gastric bypass) in the opinion of investigator -Have significant lipohypertrophy, lipoatrophy, or scars within the SC tissue in areas of infusion, in the opinion of the investigator -Have a history of abscess at an infusion site within the last 90 days prior to screening -Have vision loss or hearing loss that does not allow recognition of pump screens, alerts and alarms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the hypothesis that LY900014 is noninferior to Humalog on glycemic control ([NIM = 0.4% for HbA1c) in patients with T1D using CSII for 16 weeks; Secondary Objective: 1-To test the hypothesis that LY900014 is superior to Humalog in controlling 1 hour postprandial glucose (PPG) excursions 2-To test the hypothesis that LY900014 is superior to Humalog in controlling 2 hour PPG excursions 3-To test the hypothesis that LY900014 is superior to Humalog on improving glycemic control (HbA1c) 4-To compare LY900014 and Humalog with respect to the rate of severe hypoglycemic events 5-To compare LY900014 and Humalog with respect to the rate and incidence of documented postmeal hypoglycemia 6-To compare LY900014 and Humalog with respect to the rate and incidence of documented hypoglycaemia 7-To compare LY900014 and Humalog with respect to 1,5 AG 8-To compare LY900014 and Humalog with respect to 10 point SMBG profiles 9-To compare LY900014 and Humalog with respect to total, basal, and bolus insulin dose 10-To compare LY900014 and Humalog with respect to the proportion of patients achieving HbA1c targets ;Primary end point(s): Difference between LY900014 and Humalog in change from baseline to Week 16 in HbA1c;Timepoint(s) of evaluation of this end point: Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Week 16 for all secondary endpoints ; Secondary end point(s): 1.Difference between LY900014 and Humalog in the 1-hour PPG excursion (serum glucose measured 1 hour after the start of the meal minus fasting serum glucose) from a MMTT at Week 16 2.Difference between LY900014 and Humalog in the 2-hour PPG excursion (serum glucose measured 2 hour after the start of the meal minus fasting serum glucose) from a MMTT at Week 16 3.Difference between LY900014 and Humalog in change from baseline to Week 16 in HbA1c 4.Rate (events/ patient/100 years) of severe hypoglycemic events from baseline through Week 16 5.Rate (events/patient/year) and incidence (percent of patients with at least 1 event) of documented postmeal hypoglycemia within 1 and 2 hours after the start of the meal from baseline through Week 16 6.Rate (events/patient/year) and incidence (percentage of patients with events) of documented hypoglycemic events from baseline through Week 16 7.Change from baseline 1,5-AG values at Week 16 8.Change from baseline 10-point SMBG values at Week 16 9.Change from baseline in bolus/total insulin dose ratio at Week 16 | — |
Countries
Australia, Austria, Canada, France, Germany, Hungary, Israel, Italy, Spain, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed